Biopsy tissue sample transport device and method of using thereof

ABSTRACT

A biopsy tissue sample transport device and method of using thereof including a tissue storage assembly having a sample container, having a holding structure to hold a tissue sample, the holding structure having a sample access opening formed in a sidewall; a housing that receives the tissue storage assembly, the housing comprising an assembly insertion opening through which the tissue storage assembly is inserted into the housing; a sealing member configured to engage and substantially seal the sample access opening of the holding structure of the sample container of the tissue storage assembly; and a lid to engage and substantially seal the assembly insertion opening of the housing.

REFERENCE TO RELATED APPLICATION

This application is a divisional of U.S. application Ser. No. 14/403,898filed Nov. 25, 2014, which is a National Stage Entry ofPCT/US2013/047281 filed Jun. 24, 2013, for which reference is herebymade to U.S. Provisional Patent Application Ser. No. 61/663,295, filedJun. 22, 2012 and entitled BIOPSY TISSUE SAMPLE TRANSPORT DEVICE, U.S.Provisional Patent Application Ser. No. 61/663,310, filed Jun. 22, 2012and entitled BIOPSY TISSUE SAMPLE TRANSPORT DEVICE AND METHODS, and U.S.Provisional Patent Application Ser. No. 61/663,326, filed Jun. 22, 2012and entitled BIOPSY TISSUE SAMPLE TRANSPORT DEVICE, the disclosures ofwhich is hereby incorporated by reference and priority of which ishereby claimed pursuant to 37 CFR 1.78(a)(4) and (5)(i).

FIELD OF THE INVENTION

The present disclosure relates generally to tissue sample transportdevices, and in particular, to a tissue sample transport deviceconfigured to transport a biopsy core sample.

BACKGROUND

A biopsy is the removal of tissue to examine it for signs of cancer orother disorders. Biopsies may be open (surgically removing tissue) orpercutaneous (e.g. by fine needle aspiration, core needle biopsy orvacuum assisted biopsy). The biopsy site can be located via palpation,ultrasound, stereotactic, MRI or mammography.

Biopsy samples are obtained in a variety of ways using various medicalprocedures involving a variety of the sample collection devices.Examples of collection devices include those marketed under thetradenames MAMMOTOME (from DEVICOR MEDICAL PRODUCTS, Cincinnati Ohio),CELERO, ATEC AND EVIVA (all from HOLOGIC, Malborough Mass.), and FINESSEand ENCOR (all from BARD BIOPSY SYSTEMS, Tempe Ariz.).

Some of these systems collect the biopsy sample in a closed container.U.S. Pat. No. 8,118,775 describes a closed biopsy sample storagecontainer that is designed to spatially segregate biopsy samples duringthe collection procedure. U.S. Pat. No. 7,572,236 describes a biopsydevice with a closed container for collecting one or more samples. Thecontainer includes a basket for flushing away blood and other tissuedebris from the specimens.

After the biopsy sample is collected, the sample is analyzed at a labthat is set up to perform the appropriate tests (such as histologicalanalysis). Often, collection of the sample, and analysis of the sampleare performed at different locations and the sample must be transportedfrom the collection location (e.g. hospital, clinic, etc.) to thepathology lab for analysis.

Thus, after collection, the biopsy samples are typically removed fromthe collection container and placed into another container for transportto a pathology lab. A chemical fixative (such as formalin) is added tothe container to preserve the sample.

After the samples are removed from the patient, a tissue marker can beinserted into the biopsy site to later relocate the site, if needed. Forexample, U.S. Pat. Nos. 6,270,464, 6,356,782, 6,699,205, 7,229,417 and7,625,397 all describes tissue markers and methods for marking a biopsysite.

It is desirable to retain information collected during the biopsy witheach sample. It is also desirable to be able to later relocate theposition that the sample was taken from the biopsy site by correlatinginformation retained with the sample against the tissue marker.

Thus, there is a need for the sample or samples to be packaged fortransportation from the collection location to the pathology lab.Currently, the sample is simply placed loosely in a specimen jar filledwith the fixing agent or chemical (e.g., a solution of formaldehyde inwater such as Formalin), which preserves the biopsy sample for analysisand the specimen jar sealed for shipping. If multiple samples arecollected, multiple samples from the same patient may be placed in thesame jar for transportation.

Once the biopsy sample arrives in the pathology lab, it is removed fromthe container placed, into a cassette and processed it is then embeddedready for sectioning. It is often necessary to slice the sample into aplurality of thin sections (e.g., 2 to 25 IA thick sections), oftenusing a microtome, prior to performing any analysis. Such sectioning ofthe sample often helps a medical professional properly assess the sampleunder a microscope (e.g. diagnose relationships between cells and otherconstituents of the sample, or perform other assessments). In order toproperly section the sample, several steps are typically performed toembed the sample within a solid substrate. A commonly used solidsubstrate may include, for example, paraffin wax, which is used to holdthe sample in position while also providing a uniform consistency tofurther facilitate sectioning with the microtome. In order to properlyprocess the sample a series of steps must be performed including:

-   -   1—Fixation of the sample to immobilize molecular components        and/or prevent degradation. This is typically done with a fixing        agent or chemical (e.g., a solution of formaldehyde in water        such as formalin) shortly after sample collection.    -   2—Transferring the sample from the transportation jar to a        processing cassette. 3—Infiltrating the sample with an embedding        material, such as the paraffin wax.    -   4—Embedding the sample in the paraffin wax and sectioning using        for example a microtome.

Under existing practices, this fixing, transferring, infiltrating, andembedding must all be done manually, and such manual handling of thesample can increase the likelihood of misidentifying the sample, crosscontaminating the samples, or losing part or all of the sample. Further,as multiple samples may be placed in the same jar, and each sample ismerely loosely floating in the fixing agent, information about eachsample, such as the orientation of the sample with respect to collectionand, which sample was collected from which area of the patient (i.e., 2mm from mass, 4 mm from mass, 6 mm from mass etc.) may be lost andunavailable to the medical professional when assessing the sample.Additionally, the numerous steps of manual manipulation can oftenincrease the time that it takes to provide a proper assessment for eachsample, once the sample is collected from the patient.

SUMMARY

In view of these issues, there may be a need for a transportation devicethat can transport one or more samples while still preservinginformation regarding the collection such as patient name and details,the orientation of the sample with respect to the sample collectionsite, the number of samples collected and location from which the samplewas collected on the patient during transport between the collectionsite (e.g. hospital, clinic, etc.) and the pathology lab performing theanalysis. Further, other information regarding collection conditionssuch as time between collection of sample and placement in the fixingagent, and pH of the fixing agent may also be preserved. Additionally,there may be a need for a transportation device that may reduce theamount of manual manipulation required between sample collection andassessment by a medical professional.

Thus, example embodiments of this application may address one or more ofthe above identified issues. However, an embodiment of this applicationneed not solve, address, or otherwise improve on existing technologies.

BRIEF DESCRIPTION OF THE DRAWINGS

A general architecture that implements the various features of thedisclosure will now be described with reference to the drawings. Thedrawings and the associated descriptions are provided to illustrateembodiments of the disclosure and not to limit the scope of thedisclosure. Throughout the drawings, reference numbers are reused toindicate correspondence between referenced elements.

FIG. 1 illustrates an exploded view of a biopsy tissue sample transportdevice according to a first embodiment of the present application.

FIG. 2 illustrates an enlarged view of a pair of sample trays accordingto the first embodiment of the present application.

FIG. 3 illustrates an enlarged view of a tissue storage assemblyaccording to the first embodiment of the present application.

FIG. 4 illustrates an enlarged view of the housing and label accordingto the first embodiment of the present application.

FIG. 5 illustrates a side view of a biopsy tissue sample transportdevice having a fixing agent pouch according to the first embodiment ofthe present application in a closed and empty state.

FIG. 6 illustrates a side view of the biopsy tissue sample transportdevice having a fixing agent pouch according to the first embodiment ofthe present application in an open and empty state.

FIG. 7 illustrates a side view of the biopsy tissue sample transportdevice having a fixing agent pouch according to the first embodimentpresent application in an open state and containing a tissue storageassembly.

FIG. 8 illustrates an exploded view of a biopsy tissue sample transportdevice according to a second embodiment of the present application.

FIG. 9 illustrates an enlarged view of the housing and holding memberaccording to the second embodiment of the present application.

FIG. 10 illustrates a side view of a biopsy tissue sample transportdevice having a fixing agent pouch according to the second embodiment ofthe present application in an open state.

FIG. 11 illustrates a side view of a biopsy tissue sample transportdevice having a fixing agent pouch according to the second embodiment ofthe present application in a closed state with the breaking memberwithdrawn.

FIG. 12 illustrates a top view of the housing 3 of a biopsy tissuesample transport device having a fixing agent pouch according to thesecond embodiment of the present application in an open state.

FIG. 13 illustrates a side view of a biopsy tissue sample transportdevice having a fixing agent pouch according to the second embodiment ofthe present application in a closed state with the breaking member fullyinserted.

FIG. 14 illustrates a flowchart showing a method for preparing a tissuesample for transport according to a third embodiment of the presentapplication.

FIG. 15 illustrates an enlarged view of a transport cassette accordingto the third embodiment of the present application.

FIG. 16 illustrates a cutting jig used in the third embodiment of thepresent application.

FIG. 17 illustrates positioning one or more sample containers in atransport cassette according to the third embodiment of the presentapplication.

FIG. 18 illustrates one or more sample containers position in atransport cassette according to the third embodiment of the presentapplication.

FIG. 19 illustrates a closed transport cassette according to the thirdembodiment of present application.

FIGS. 20A and 20B illustrates a transport cassette having anincorporated cutting element according to another embodiment of thepresent application.

FIG. 21 illustrates insertion of a transport cassette into atransportation apparatus according to a third embodiment of the presentapplication.

FIG. 22 illustrates insertion of a transport cassette into atransportation apparatus according to a fourth embodiment of the presentapplication.

FIGS. 23A-23B illustrate a transport cassette into a transportationapparatus according to a fifth embodiment of the present application.

FIG. 24 illustrates a transport cassette into a transportation apparatusaccording to another exemplary embodiment of the present application.

FIG. 25 illustrates a tray next to a tissue cassette according to anexample embodiment of the present application.

DETAILED DESCRIPTION

In the following detailed description, reference will be made to theaccompanying drawing(s), in which similar elements are designated withsimilar numerals. The aforementioned accompanying drawings show by wayof illustration and not by way of limitation, specific exampleembodiments and implementations consistent with principles of an exampleembodiment. These implementations are described in sufficient detail toenable those skilled in the art to practice an example embodiment and itis to be understood that other implementations may be utilized and thatstructural changes and/or substitutions of various elements may be madewithout departing from the scope and spirit of an example embodiment.The following detailed description is, therefore, not to be construed ina limited sense.

Embodiment 1

FIG. 1 illustrates an exploded view of a biopsy tissue sample transportdevice 1 according to a first embodiment of the present application. Thebiopsy tissue sample transport device 1 of this example comprises atissue storage assembly 2, a housing 3, and a lid 4. The tissue storageassembly 2 comprises at least one sample tray (in this embodiment twotrays are shown as 5A, 5B) and a bracing member 6. The tissue storageassembly 2, the sample trays 5A, 5B, and the bracing member 6 arediscussed in more detail below. In some embodiments, the housing 3 mayhave a label 8 attached to housing 3.

In one embodiment, the tissue storage assembly 2 is sized and shaped tofit a Mammotome system. In one embodiment, the tissue storage assembly 2is as described in FIGS. 10-16 and the corresponding description inparagraphs [0070] to [0078] in US 2012/0065542 (published Mar. 15,2012), incorporated herein by reference in its entirety.

FIG. 2 illustrates an enlarged view of a pair of sample trays 5A, 5B.Sample tray 5A is substantially similar to sample tray 5B, and thus onlysample tray 5A will be discussed in detail. Any differences betweensample tray 5A and 5B will be noted. Though a pair of sample trays 5A,5B are described in the present embodiment. However, an embodiment mayuse more or less than 2 trays 5A, 5B and all descriptions of a pair oftrays 5A, 5B, should not be limited to requiring two trays, and may forexample, include a single tray. Sample tray 5A comprises a plurality ofsample containers 10, each sample container having a holding structure12 configured to releasably hold a tissue sample collected during abiopsy procedure. Each holding structure 12 may have a sample accessopening 14 through which tissue samples may enter or exit the holdingstructure 12.

In the embodiment shown in FIG. 2, the holding structure 12 consists oflongitudinal sidewalls and two end walls defining a longitudinalchamber. In this embodiment, the sample access opening 14 may be formedthrough one of the end walls. Further, in this embodiment the holdingstructure 12 may be open on one of the sidewalls such that tissuesamples may be viewed, and tactile examinations can be performed (i.e.,a medical professional may touch) on the sample without removing thesample from the holding structure 12. The tissue samples from which thebiopsy is taken can be bone, bone marrow, breast, cervical, joint,kidney, liver, lymph node, lung, pleural, prostate, small intestine,skin, synovial, thyroid, parathyroid, stomach, esophagus, oral cavity,pharynx, larynx, colon, rectal, anus, bladder, pancreas, spleen, centralnervous system, peritoneum, genital, reproductive organ, heart andmediastinum. The present application may be useful when multiple samplesare taken from a patient. Breast tissue is particularly amendable to usewith VAB procedures. However, the holding structure 12 is not limited tothis embodiment, and may have alternative structures. For example, theholding structure 12 may have a chamber, which is a cylindrical shape,ovoid shape, triangular shape, or any other shape sized to receive abiopsy core sample as would be apparent to a person of ordinary skill inthe art. Further, the holding structure's sample access opening 14 maybe formed in a sidewall or an end wall, or may have multiple sampleaccess openings 14 formed in multiple end walls, longitudinal walls orboth longitudinal and end walls. Further, although the holding structure12 in FIG. 2 is open at on one sidewall, embodiments of the holdingstructure may be completely enclosed on all walls.

Each of the plurality of sample containers 10 which make up the sampletray 5A may be connected together by a joining member 16. The joiningmember 16 may connect the sample containers 10 along a portion or thewhole of an end wall. The joining member 16 is preferably capable ofbeing laid flat on a surface. In some embodiments, it is made of aflexible (or bendable) material. In other embodiments, it can be hingedbetween sample containers to allow it to flex. In the embodiment of FIG.2, the sample containers 10 are only connected by a flexible joiningmember 16. The sample containers 10 may also be connected to each otheralong their length.

The sample trays 5A, 5B may be formed from a variety of materials andtheir construction is not particularly limited. The sample trays 5A, 5Bmay be constructed from a material that has one or more of the followingfeatures: transparent on imaging or with minimal interference (i.e.radio transparent), resistant to chemical fixatives (such as formalin),resistant to degradation from chemicals used in tissue processing (suchas alcohol, xylene or acids), resistant to temperatures used in tissueembedding, and sectionable (e.g. with a microtome). Exemplary materialsfor forming the sample trays 5A, 5B include thermoplastic materials,including polyolefins (e.g., polyethylene, polypropylene, Teflon, etc.),polycarbonate, polystyrene, polyacetals, polyesters, polyamides (e.g.nylon), polyurethanes, silicone, and copolymers thereof (e.g. FEP) andcombinations thereof.

FIG. 3 illustrates an enlarged view of the tissue storage assembly 2,which comprises at least one sample tray 5A, 5B and a bracing member 6.The bracing member 6 shown in FIG. 3 has a generally cylindrical shape,and comprises one or more chambers 18, which extend lengthwise throughthe bracing member 6. As shown in FIG. 3, the bracing member 6 alsoincludes a first opening 20 formed at a topside of each of the chambers18, and a second opening 22 formed at a bottom side of each of thechambers 18. Each of the chambers 18 of the bracing member 6 may receiveone of the sample containers 10 of the sample trays 5A, 5B. Each of thesample containers 10 of the sample trays 5A, 5B may be inserted througheach of the first openings 20 and into the corresponding chamber 18 ofthe bracing member 6. Further, the sample access openings 14 of each ofthe sample containers may be oriented downward to align with the secondopening 22 formed a bottom side of each of the chambers 18.

The material used for the bracing member 6 is not particularly limited,and may include the same or different materials used to form the tray.In some cases, the bracing member is made from the same material as thetray and is manufactured as part of the tray. The bracing member maycontain one or more tabs to allow the user to easily manipulate the trayout of the biopsy device and into the transport container.

FIG. 3 also illustrates that each of the sample containers 10 may belabeled with a unique identifier 24 which may allow each sample to beuniquely identified and distinguished during later testing.

FIG. 4 illustrates an enlarged view of the housing 3 and label 8. InFIG. 4, the housing is generally cylindrical in shape and includes asidewall 26 and an assembly insertion opening 28. The assembly insertionopening 28 is configured to allow the tissue storage assembly 2 to beinserted into the interior of the housing. More specifically, theassembly insertion opening 28 is sized and shaped so that the tissuestorage assembly 2 can pass easily into the interior of the housing.Further, a closing portion 30 may be disposed proximate to the assemblyinsertion opening 28, and the closing portion 30 may interact with thelid 4 (not shown) to seal and close the assembly insertion opening 28.The closing portion 30 may be a threaded fitting, a pressure fitting, orany other fitting capable of sealing with a lid to prevent liquidleakage as would be apparent to a person of ordinary skill in the art.

Further, the housing 3 may also have a sealing member 32 configured tointeract with the tissue storage assembly 2 to block the sample accessopenings 14 of the individual sample containers 10 of the sample trays5A, 5B. Specifically, the sealing member 32 may cover the openings ormay include one or more protrusions which extend upward from a surfaceof the sealing member and are sized and shaped to be inserted throughthe second openings 22 formed in the bottom of the bracing member 6, andinto each of the sample access openings 14 of the individual samplecontainers 10 of the sample trays 5A, 5B.

Alternatively, the sealing member 32 may include a single protrusionconfigured to engage and seal multiple sample access openings 14 ofmultiple individual sample containers 10 of the sample trays 5A, 5B. Thesize and shape of the protrusions are not particularly limited, may beany size and shape which can create a sufficient seal with the sampleaccess openings 14 of the individual sample containers 10 of the sampletrays 5A, 5B to prevent tissue samples from falling out of the sampletrays 5A, 5B. For example, the sealing member may be annularly shaped asshown in FIG. 4.

The sealing member 32 may be removably affixed to the bottom of thehousing 3 such that it can be transferred to the at least one tray 5A,for example. For example, one or more of the protrusions on the sealingmember 32 may engage the sample access opening 14 of one of theindividual sample containers 10 of a tray 5A, attaching to the tray andreleasing from the bottom of the housing. Such removable attachment maybe achieved using mechanical means such as a tongue and grooveconfiguration, a releasable tab configuration, or any otherconfiguration of removably attaching the sealing member 32 to thehousing 3. Alternatively or additionally, the removable attachment maybe achieved using an adhesive which degrades upon adding fixing agent tothe housing to preserve the samples.

Additionally, the housing 3 may also include a bottom 33 disposed on aside of the housing opposite the assembly insertion opening 28. In someembodiments, the bottom may be removable to form an assembly removalopening (not shown) to allow the assembly to be removed through. In FIG.4, the assembly removal opening would be disposed at the bottom of thecylindrical housing 3. The assembly removal opening may be sized andshaped so that the tissue storage assembly 2 can pass easily out of theinterior the housing 3. By providing a separate assembly insertionopening 28, the closing portion 30 may be configured to lock the lid 4(not shown) in place upon sealing such that the lid could not bereopened once sealed. Further, by providing an assembly removal opening29 at the bottom of the housing, the tissue samples may be removedthrough the bottom of the housing 3.

Additionally, the sealing member 32 may be removably attached to theremovable bottom which seals and closes the assembly removal opening 29.

The material of the housing 3, including the sealing member 32, and thelid 4 is not particularly limited and may include polymer materials,resin materials, and ceramic materials (e.g. plastics, resins, andceramic/glass). Additionally, the material of housing 3 and lid 4 may beconstructed from a material has one or more of the followingcharacteristics: transparent on imaging or with minimal interference(i.e. radio transparent), resistant to chemical fixatives (such asformalin), resistant to degradation from chemicals used in tissueprocessing (such as alcohol, xylene or acids), and resistant totemperatures used in tissue embedding. Exemplary materials for formingthe housing 3 and lid 4 may include thermoplastic materials, includingpolyolefins (e.g., polyethylene, polypropylene, Teflon, etc.),polycarbonate, polystyrene, polyacetals, polyesters, polyamides (e.g.nylon), polyurethanes, silicone, and copolymers thereof (e.g. FEP) andcombinations thereof.

FIG. 4 also shows the label 8 which may be attached to the housing 3.The label 8 may be a human and/or computer readable label upon whichinformation about the patient, the collected sample, and collectionconditions may be retained. The information retained with the sample cancomprise one or more of patient name, patient accession number, businessaddress information, hospital address information, social securitynumber information, patient medical history information, dateinformation, biopsy time information, location information (e.g.location within a patient (e.g. duct or lobule in breast), within atargeted biopsy site, relative to the position of another biopsy sample,or relative to a biopsy marker located within a patient), and the timethat the fixative is contacted with sample. Additional informationretained may also include pH of fixing solution at time of fixation ofthe sample, and temperature of fixation solution, etc. Additionally, thelabel may include unique identifying information for each of theplurality of samples being transported.

In some embodiments, the label 8 may be a computer readable tag or labelincluding, but not limited to, labels having an incorporated RFID tag,labels having an incorporated one-dimensional (1-D barcode),two-dimensional barcode (2-D barcode), and labels having an incorporatedthree-dimensional barcode (3-D barcode). However, the computer readablelabel is not limited to RFID, 1-D barcode, 2-D barcode, or 3-D barcodelabels and may include any type of label readable by a computer as wouldbe apparent to a person of ordinary skill in the art.

In some embodiments, more than one tag may be present. When more thanone tag is present, they can be physically separated or locatedtogether. In one embodiment, a tag may be associated with each holdingstructure or a group of holding structure so that if the holdingstructures are later detached from each other, a tag remains with eachsample or group of samples.

In some embodiments, a tag is present that may be sensitive to changesto the sample or to the tray itself. For example, a tag may be presentthat changes physical (i.e. color) or chemical (i.e. redox, conjugation,etc.) properties during fixation of the sample. Similarly, a tag may bepresent that is sensitive to the processing steps which precedeembedding (i.e. dehydration). Alternatively, a tag may be present thatis sensitive to the embedding step (i.e. infiltration of wax). The tagmay have a property that changes incrementally or switches when the stepis complete. In this way, the technician, or an automated system, willbe able to determine when the sample has finished one step beforeanother is started.

In another embodiment, a tag may be present that directs processing ofthe tissue in a tissue processor (such as a PELORIS or ASP systemsavailable from LEICA, Wetlzar Germany). For example, the tag may directa tissue processing unit to use a protocol designed for fatty breasttissue versus muscle tissue.

In FIGS. 1 through 4, the label 8 is shown attached to the housing 3,but embodiments of the present application are not limited to the labelbeing attached to the housing. Embodiments of the present applicationmay include the label 8 being attached to one or more of the tissuestorage assembly 2 (the tray 5A, 5B, the bracing member 6, or individualsample containers 10), the lid 4, or the housing 3.

Fixing Agent Handling Components

As discussed above, in order to preserve the one or more collectedbiopsy tissue samples for subsequent histological analysis, it isnecessary to perform a fixation process on the sample (i.e. submergingthe sample in a bath of fixation solution). Typical fixation techniquesinclude, fixation in acetone, methanol, ethanol, methanol acetone (e.g.,fix in methanol, remove excess methanol, permeabilize with acetone),methanol-acetone mix (e.g., 1:1 methanol and acetone mixture),methanol-ethanol mix (e.g., 1:1 methanol and ethanol mixture), formalin,paraformaldehyde, gluteraldehyde, Histochoice, Streck cell preservative(Streck Labs., Nebraska), Bouin's solution (a fixation system containingpicric acid), Sed-Fix (a polyethylene glycol based fixation systemavailable from Leica Biosystems, Buffalo Grove Va.), FineFix (LeicaBiosystems, Buffalo Grove Va.), Carnoys, Modified Carnoys/Clarkessolution, Ethanol, FineFX, Methacarn, Methanol, Molecular Fixative(UMFIX), BoonFix, Polyethylene glycol based fixatives, RCL2, Uni-Fix,Glyco-Fix, Gluteraldehyde, HistoCHOICE, HistoFix, HOPE Fixation, Ionicliquid, Mirsky's fixative, NOTOXhisto, Prefer, Preserve, Zenker or anyother fixing agent as would be apparent to a person of ordinary skill inthe art.

In some embodiments, the fixative may be poured into the containerbefore sealing. In some embodiments, the fixative may be provided as atablet or powder and be added to the container and then rehydrated withwater. However, at least some of these fixing solutions pose moderate tosevere risks to humans, and thus must be handled with care. Thus, someembodiments of the present application may include fixing agent handlingcomponents which may reduce the need for a person to directly handle afixing solution by maintaining the fixing solution (or a dehydratedpowder or tab) in a sealed area, and releasing the fixing solution intothe transportation device in response to a specific action.

FIG. 5 illustrates a side view of a biopsy tissue sample transportdevice having a fixing agent pouch according to the first embodiment ofthe present application in a closed and empty state. FIG. 6 illustratesa side view of the biopsy tissue sample transport device having a fixingagent pouch according to the first embodiment of the present applicationin an open state. FIGS. 5 and 6 illustrate an embodiment of atransportation device similar to the first embodiment discussed above,further including a fixing agent pouch 34 disposed in a lid 4 designedto engage the housing 3. Again, the housing 3 includes a sidewall 26, atissue storage assembly insertion opening 28, a closing portion 30 and asealing member 32.

Further, as shown in FIG. 5, the closing portion 30 is a threaded regioncomprising a plurality of threads 30 a which engage a plurality ofthreads 30 b of the lid 4 to seal the lid 4 to the housing 3.

The fixing agent pouch 34 may be filled with a fixing solution 36, whichwill preserve any tissue samples stored in the housing 3. Further, thefixing agent pouch 34 also has a frangible portion 38, which is designedto be broken or ruptured to allow the fixing solution 36 be releasedinto the housing 3 based on a specific action. The frangible portion 38may be a perforated region or a region formed of a material from theremainder of the fixing agent pouch 34, such that the fixing agent pouch34 can be caused to break in a predictable manner.

FIG. 7 illustrates the embodiment of the transportation device with thefixing agent pouch 34 disposed to lid 4 with a tissue storage assembly 2inserted through the tissue storage assembly insertion opening 28 andinto the housing 3. Further, a breaking member 40 is also disposedwithin the housing 3. In FIG. 7, the breaking member 40 is a needleshaped member configured to engage the frangible portion 38 of thefixing agent pouch 34 upon closing and sealing of the lid 4 to thehousing 3. Specifically, the needle shaped breaking member 40 isoriented to point upward, and the fixing agent pouch 34 is suspendedfrom the lid 4 such that the frangible portion 38 is oriented downward.As the lid 4 is lowered onto the housing 3, the frangible portion 38 ofthe fixing agent pouch 34 is forced downward onto the pointed end of thebreaking member 40. As the closing portion 30 engages the lid 4,additional force is exerted on the frangible portion 38 by the breakingmember 40 causing the frangible portion 38 to rupture and release thefixing agent 36 into the housing and submerge the biopsy tissue samplesstored in the tissue storage assembly 2. The volume of fixing solution36 provided is chosen to be sufficient to fill housing 3 such that thebiopsy tissue samples in the sample trays 5A, 5B are submerged.

Further, in the above embodiment, the breaking member 40 is needleshaped and oriented upward, and the frangible portion 38 of the fixingagent pouch 34 is located at a bottom side of the fixing agent pouch 34.However, the breaking member 40 is not limited to a needle shaped normust it be oriented upward. Further, the frangible portion 38 of thefixing agent pouch 34 need not be located at a bottom side of the fixingagent pouch 34, but may be located anywhere on the fixing agent pouch 34or the entire fixing agent pouch 34 may be frangible. An embodiment ofthe breaking member 40 and the fixing agent pouch 34 may have anyalternative orientation as would be apparent to a person or this coming.

Embodiment 2

FIG. 8 illustrates an exploded view of a biopsy tissue sample transportdevice 1 according to a second embodiment of the present application.The biopsy tissue sample transport device 1 of this embodiment mirrorsthe embodiment described above having a housing 3 and a lid 4. However,this embodiment includes a tissue storage assembly 2 with at least onesample tray 5A, 5B, but does not include a bracing member 6. The sampletrays 5A, 5B of the tissue storage assembly were discussed in detailabove with respect to FIG. 2 above and redundant discussion is omitted.The biopsy tissue sample transport device 1 of this embodiment alsoincludes one or more holding members 42 configured to engage and sealone or more of sample containers 10 of the sample trays 5A, 5B. Theholding members 42 are discussed in more detail below with respect toFIG. 9.

FIG. 9 illustrates an enlarged view of the housing 3 and holding member42. In FIG. 9, the housing 3 is similar to the embodiment describedabove and is generally cylindrical in shape and includes a sidewall 26and an assembly insertion opening 28. Further, the housing 3 may alsoinclude an interior region 44 which may include one or morelongitudinally extending slots 46 (example embodiments of thelongitudinal slots 46 are shown in FIGS. 10 through 13), each slot maybe sized and shaped to receive one or more of the sample containers 10of the sample trays 5A, 5B. In some embodiments, this longitudinal slot46 extends the length (i.e. height) of the housing 3 such that each ofthe sample containers is held in an upper right orientation. Further,the longitudinal slot 46 may have an are shape (shown in FIG. 12)extending at least partially along a circumferential direction of thecylindrical housing.

Further, similar to the embodiment above the closing portion 30 may bedisposed proximate to the assembly insertion opening 28, and the closingportion 30 may interact with the lid 4 (not shown) to seal and close theassembly insertion opening 28. The closing portion 30 may be a threadedfitting, a pressure fitting, or any other fitting capable of sealingwith a lid to prevent liquid leakage as would be apparent to a person ofordinary skill in the art.

Further, one or more holding members 42 may be inserted into the housing3. Each holding member 42 may include a longitudinal portion 48 and ahorizontally extending portion 50 attached at one end of thelongitudinal portion. Each holding member 42 may have an are shape,which is sized and shaped to conform to the are shape of thelongitudinally extending slot 46 of the housing 3 such that thelongitudinal portion 48 of the holding member 42 extends along thesidewall of the slot 46 in a horizontal portion 50 rests at a bottom ofthe are shaped slot 36. However, the holding member 42 is not limited toan are shape, and may have any shape which fits into the slot 46 of thehousing 3.

Each holding member 42 may be configured to interact with the tissuestorage assembly 2 to seal the sample access openings 14 of theindividual sample containers 10 of the sample trays 5A, 5B (similar tothe sealing member disclosed in Embodiment 1). Specifically, the holdingmember 42 may include one or more holding portions 52. The holdingportions may be flat regions or may be protrusions 54, which extendupward from a surface of the holding member 42. Each protrusion 54 maybe sized and shaped to block access to or to be inserted into each ofthe sample access openings 14 of the individual sample containers 10 ofthe sample trays 5A, 5B.

Alternatively, the holding member 42 may include a single protrusion 54configured to engage and seal multiple sample access openings 14 ofmultiple individual sample containers 10 of the sample trays 5A, 5B. Thesize and shape of the protrusions are not particularly limited, and maybe any size and shape which can create a sufficient seal with the sampleaccess openings 14 of the individual sample containers 10 of the sampletrays 5A, 5B to prevent tissue samples from falling out of the sampletrays 5A, 5B.

The holding member 42 may be removably affixed to the bottom of theslots 46 of the housing 3 such that when one or more of the protrusionsengages the sample access opening 14 of one of the individual samplecontainers 10, the holding member 42 becomes attached to the samplecontainer 10 or sample tray 5A, 5B. For example, in FIG. 9 a tab 43 isprovided at one end of each of the holding members 42 and the tab 43 isconfigured to engage one of the sample trays 5A, 5B, after the sampletray 5A, 5B is inserted into the slot 46 of the housing 3.

The removable attachment between the holding member 42 and housing 3 maybe achieved using mechanical means such as a tongue and grooveconfiguration, a releasable tab configuration, or any otherconfiguration of removably attaching the holding member 42 to thehousing 3. Alternatively, the removable attachment may be achieved usingan adhesive which degrades upon adding fixing agent to the housing topreserve the samples.

The fixing agent pouch may also be disposed within the lid 4 similar tothe fixing agent pouch described above with respect to the firstembodiment without significant modification. Alternatively, FIGS. 10-13illustrate the fixing agent pouch 34 disposed within the housing 3. FIG.10 illustrates the housing 3 and the lid 4 in a pre-sealedconfiguration. FIG. 11 illustrates the housing 3 and the lid 4 in asealed configuration. FIG. 12 illustrates a top view of the housing 3prior to scaling of the lid 4 to the housing 3.

In FIG. 10, pair of tissue storage trays 5A, 5B, which form a tissuestorage assembly 2, have been inserted into the pair of longitudinallyextending slots 46, and each tray 5A, 5B has engaged a holding member42.

In this embodiment, the closing member 30 includes a plurality ofthreads 56 configured to engage the lid 4 to form a seal. Further, inthis embodiment the housing 3 also includes a central cylindricalregion. The fixing agent pouch 34 is disposed within the centralcylindrical region. The fixing agent pouch 34 is filled with a fixingsolution 36, and includes a frangible portion 38 configured to ruptureand release the fixing solution 36 into the housing in response to aspecific action.

In this embodiment, the lid 4 includes a breaking member 40. In thisembodiment the breaking member 40 is a plunger member configured toengage the top surface of the fixing agent pouch 34 when the lid 4 issealed to the housing 3. A sealing 41 may be formed at one end of thebreaking member 40 to prevent fluid leakage around the breaking member40 and provide a leak-proof seal in the lid 4. When the lid 4 is sealedto the housing 3, the breaking member 40 rests on top of the fixingagent pouch 34 and is substantially aligned with the central cylindricalregion of the housing 3.

FIG. 13 illustrates the effect of pressing the plunger shaped breakingmember 40 through the lid 4 and into the central cylindrical region ofthe housing 3. As the breaking member 40 is pressed downward, asqueezing force is applied to the fixing agent pouch 34 increasing thepressure of the fixing solution 36. When the pressure of the fixingsolution 36 exceeds a breaking strength of the frangible portion 38, thefrangible portion 38 ruptures and the fixing solution 36 is forced outof the central cylindrical region and into the longitudinally extendingslots 46. The volume of fixing solution 36 provided is chosen to besufficient to fill the longitudinally extending slots 46 such that thebiopsy tissue samples in the sample trays 5A, 5B are submerged.

Though the above discussed embodiment shows a fixing agent pouchdisposed within housing 3 of a tissue transport device consistent withthe second embodiment of figures, a fixing agent pouch may also bedisposed within the housing 3 of the first embodiment, withoutsignificant modification. Further, in the above embodiment, the breakingmember 40 is a plunger shaped member and is oriented downward, and thefixing agent pouch 34 is located in a central region of the housing 3.However, the breaking member 40 and fixing agent pouch 34 need not havethis configuration. For example, the fixing agent pouch 34 may bedisposed within the lid 4 of the transportation device, and an upwardfacing protruding member may be disposed within the housing, such thatthe act of pressing the lid 4 onto the housing 3 causes the fixing agentpouch to be compressed by the upward facing protruding member, therebysqueezing fixing agent solution out of the pouch and into the remainderof the housing.

Further, the frangible portion 38 of the fixing agent pouch 34 need notbe located at a bottom side of the fixing agent pouch 38, but may belocated anywhere on the fixing agent pouch 34 or the entire fixing agentpouch 34 may be frangible. An embodiment of the breaking member 40 andthe fixing agent pouch 34 may have any alternative orientation as wouldbe apparent to a person of ordinary skill in the art.

Embodiment 3

A third exemplary embodiment is disclosed with respect to FIGS. 14-21.FIG. 14 illustrates the steps involved with using the transport deviceinvolved with this embodiment. This embodiment mirrors the previousembodiments, however, after receiving a tissue storage assembly 2similar to the one disclosed above (step 1001), the trays 5A, 5B areseparated from the joining member 16 (step 1002) and held by aprocessing cassette 60, which inserts into the housing 3 and is closedby the lid 4 (step 1003).

FIG. 15 illustrates an example of the processing cassette 60. Theprocessing cassette 60 includes a cassette housing 62, and a cassettelid 64. The cassette lid 64 may include a holding structure 66 to holdthe tissue sample in place and maintain its orientation duringsubsequent processing. Further, the cassette lid 64 also includes alatching member 68 to hold the cassette 60 closed. The attachmentbetween the cassette lid 64 and a cassette housing 62 of the cassette 60is not particularly limited, and may include a hinge structure, a snapfit structure, or any other structure to hold the cassette lid 64 to thecassette housing 62 as would be apparent to a person of ordinary skillin the art.

FIG. 16 illustrates an example embodiment of a cutting jig 70 used tocut the joining member 16 and separate the plurality of samplecontainers 10. The cutting jig 70 includes a bottom member 72 and a topmember 74. The bottom member 72 has a recess 73 shaped and sized toreceive one or more of the sample trays 5A, 5B. Further, a cuttingelement 76 is mounted to the top member 74 and aligned with the assemblyinsertion opening 28 of the joining member such that when top member 74is brought down toward the bottom member 72, the cutting element 315cuts through the joining member 16.

After the sample containers 10 are separated they are placed in acassette 60. FIG. 17 illustrates an example of three of the individualsample containers 10 being inserted into the housing 18 of theprocessing cassette 60. As shown in FIG. 17, the sample containers 10are aligned such that the biopsy core samples are relatively parallel toeach other and are inserted into the cassette housing 62 of the cassette60. FIG. 17 also shows that in some embodiments the processing cassettehousing 62 of the cassette 60 may also include an inclined portion 76formed at one end. After the sample containers 10 are inserted into thecassette housing 62, the cassette lid 64 (shown in FIG. 15) may beclosed to secure the sample containers 10 within the cassette 60.

FIG. 18 illustrates the cassette 60 after three sample containers 10have been inserted into the cassette housing 62. FIG. 19 illustrates thecassette 60 after the cassette lid 64 has been attached to close thecassette 60. After the cassette lid 64 has been closed, the samplecontainers 10 are enclosed within the cassette housing 62.

It should be noted that in the embodiment discussed above, a separatecutting jig 70 is used to cut the joining member 16 and after thejoining member 16 is cut, the sample containers 10 are positioned in thecassette 60. However, these events need not occur in the sequence and aseparate cutting jig 70 is not required.

For example, the cutting element could be incorporated into thecassette. FIG. 20A illustrates an example embodiment of a cassette 60 inwhich the cutting element 76 is incorporated in the cassette lid 64.Thus, as shown in FIG. 20B, as cassette lid 64 is closed, the cuttingelement 76 is driven through the joining member 16 to separate one ormore of the sample containers 10 from the remainder of sample tray 5A,5B. The cutting element 76 may alternatively be incorporated into thecassette housing 62. Alternatively, a separate cutting lid (not shown)may be configured to snap onto the cassette housing 62 to cut thejoining member 16 and then be removed and replaced with the cassette lid64.

The material used for the cassette 60 is not particularly limited, andmay include the same or different materials used to form the tray. Insome cases, the cassette 60 is made from the same material as the trayand is manufactured as part of the tray.

The sample cassette 60 may be placed into a shipping transportationcontainer transportation. In FIG. 21, the transportation apparatusincludes a lid 4 and a housing 3 and similar in all aspects to theembodiments discussed above.

In FIG. 21, the attachment of the label 8 to one or more of the samplecontainers 10, the lid 4, the cassette 60 and/or the housing 3 is doneduring step 1006 of the method of FIG. 14. However, the attachment ofthe label 8 may occur at any point during the method of FIG. 14 and neednot be the last step as shown in FIG. 14.

In FIG. 21, the cassette 60 is inserted in a horizontal orientation,such that the cassette lid 64 of the cassette 60 is substantiallyparallel to the lid 4. Alternatively, the cassette 60 may be inserted ina vertical orientation, such that the cassette lid 64 of the cassette 60is substantially parallel to the sidewall 26 of the housing 3.

As noted above, after the cassette 60 is inserted into the transportdevice 1 a fixing agent chemical is added or released into thetransportation container. In order to preserve the one or more collectedbiopsy tissue samples for subsequent histological analysis, it isnecessary to perform a fixation process on the sample (i.e. submergingthe sample in a bath of fixation solution).

In this way, the trays can be used to support and orient the biopsysamples throughout the histopathology workflow. Either prior to fixationor after fixation, the samples in the trays can be imaged (by MRI,x-ray, etc.). Thereafter, the trays embedded with wax. Thereafter, thesamples (in the trays) can be sectioned with a microtome, and slides canbe prepared and stained.

Embodiment 4

FIG. 22 illustrates another exemplary embodiment of a biopsy sampletransport device 10 according to a fourth exemplary embodiment of thepresent application. The biopsy sample transport device 10 mirrors theabove described embodiments, however in this embodiment, the biopsysample transport device 10 has a substantially rectangular shape and isformed by a lower housing member 80 and an upper housing member 82.Further, a sealing gasket 84 is disposed at the interface between thelower housing member 80 and the upper housing member 82.

The connection between the lower housing member 80 and the upper housingmember 82 is not particularly limited, and may include one or more of atongue and groove configuration, a snap fitting configuration, apressure fitting configuration or any other configuration as would beapparent to a person of ordinary skill in the art. Additionally, thesealing gasket 84 is not particularly limited and may be a rubbergasket, a plastic gasket, and 0-ring, or any other sealing member aswould be apparent to a person of ordinary skill in the. Similar to theembodiments above, the biopsy sample transport device 10 of FIG. 22 isconfigured to receive one or more sample trays 5A, 5B such that the oneor more sample containers 10 are horizontally disposed and aligned in asubstantially parallel manner. Such a configuration may permit theorientation of the biopsy core samples disposed within the samplecontainers to do be maintained during transportation and handling. Inthis embodiment, similar to the embodiments discussed above, a fixingagent pouch may be provided in the transport device 10. The fixing agentpouch may be provided in the upper housing or lower housing.Alternatively, the lower housing may have two chambers in which thesample trays are in one chamber and the fixing agent pouch is in anotherchamber.

Embodiment 5

FIG. 23A illustrates a top view of a biopsy sample transport device 10according to a fifth exemplary embodiment of the present application.FIG. 2313 illustrates a side view of the biopsy sample transport device10 according to the fifth embodiment of the present. This embodimentmirrors the embodiments discussed above, however, in this embodiment,the biopsy sample transport device 10 has a substantially cylindricalshape. Further, in some embodiments, the upper housing member 82 mayhave a chamber 86 which may enclose a fixing agent pouch for preservingbiopsy samples during transport.

Alternatively, as shown in FIG. 24, the transport device 10 is sized tohold a single sample tray 5A having a plurality of sample containers 10.

Methods of Processing Biopsy Samples

The sample transport device of the present application is envisioned toallow the biopsy sample to proceed from patient through a histopathologylab with minimum human contact. By way of example, the sample tray 5Awill receive the sample from the biopsy device. It can be removed fromthe device and placed in a container of formalin (either as describedherein or via any container). Either prior to fixation or afterfixation, the samples in the trays can be imaged (by MRI, x-ray, etc.).Following fixation, the tray can be cut to fit into a standard tissuecassette such as shown in FIG. 25. In FIG. 25, the bracing member 6 ofthe tray 5A can be cut down and one or more holding structures 12 can beseparated from the others and placed into the tissue cassette.Thereafter, the tissue cassette can be processed and thereafter thetrays embedded with wax. Thereafter, the samples (in the trays) can besectioned with a microtome, and slides can be prepared and stained. Inthis way, the trays can be used to support and orient the biopsy samplesthroughout the histopathology workflow.

Although a few example embodiments have been shown and described, theseexample embodiments are provided to convey the subject matter describedherein to people who are familiar with this field. It should beunderstood that the subject matter described herein may be embodied invarious forms without being limited to the described exampleembodiments. The subject matter described herein can be practicedwithout those specifically defined or described matters or with other ordifferent elements or matters not described. It will be appreciated bythose familiar with this field that changes may be made in these exampleembodiments without departing from the subject matter described hereinas defined in the appended claims and their equivalents. Further, anydescription of structural arrangement of components or relationshipthere between is merely for explanation purposes and should be used tolimit an example embodiment.

Aspects related to the example embodiment have been set forth in part inthe description above, and in part should be apparent from thedescription, or may be learned by practice of embodiments of theapplication. Aspects of the example embodiment may be realized andattained using the elements and combinations of various elements andaspects particularly pointed out in the following detailed descriptionand the appended claims.

It is to be understood that both the foregoing descriptions arc anexample and arc explanatory only and are not intended to be limiting.

What is claimed is:
 1. A biopsy tissue sample transport devicecomprising: a tissue storage assembly having a plurality of samplecontainers, each sample container comprising a holding structureconfigured to releasably position a tissue sample, such that theplurality of sample containers are connected at one end by a flexiblemember; a housing configured to receiving the tissue storage assembly,and hold the plurality of sample containers such that each of the samplecontainers is substantially aligned with at least one adjacent samplecontainer in a substantially planar orientation, such that the pluralityof sample containers are non-overlapping when viewed from at least oneangle; and a lid configured to engage and substantially seal thehousing, wherein the flexible member is extended away from the samplecontainers in a longitudinal direction of each of the plurality ofsample containers.
 2. The biopsy tissue sample transport deviceaccording to claim 1, a. wherein the housing is a substantiallyrectangular-shaped housing configured to hold the plurality of samplecontainers in a substantially horizontal orientation.
 3. The biopsytissue sample transport device according to claim 1, further comprising:a sealing member comprising a body and at least one protrusion extendingfrom a surface of the body, the at least one protrusion configured to beinserted into an substantially seal a sample access opening formed in asidewall of at least one of the sample containers, wherein the housingcontains the tissue storage assembly therein, wherein the sealing memberis a structure arranged on an inner wall of the housing and is projectedin a first direction, from the inner wall to the assembly insertionopening, so as to engage and seal the sample access opening by abuttingthe sample access opening, and wherein the first direction is parallelto a second direction through which the assembly insertion opening ofthe housing receives the tissue storage assembly, wherein the sealingmember comprises an annular shaped member disposed at a bottom of thehousing, and the at least one protrusion of the sealing member extendingupward from the annular shaped member, and wherein the tissue storageassembly is inserted into the housing such that the sample accessopening formed in the sidewall of the holding structure of the at leastone sample container is oriented downward to engage the at least oneprotrusion of the sealing member.
 4. The biopsy tissue sample transportdevice according to claim 1, wherein the flexible member is extendedaway from the sample containers in the longitudinal direction of each ofthe plurality of sample containers, in which the tissue storage assemblyis configured to be received in the housing, such that, when the tissuestorage assembly is received in the housing, at least part of theflexible member is arranged at a different position along thelongitudinal direction than the plurality of sample containers.
 5. Abiopsy tissue sample transport device comprising: a tissue storageassembly having a plurality of sample containers, each sample containercomprising a holding structure configured to releasably position atissue sample, such that the plurality of sample containers areconnected at one end by a flexible member; a housing configured toreceiving the tissue storage assembly, and hold the plurality of samplecontainers such that each of the sample containers is substantiallyaligned with at least one adjacent sample container in a substantiallyplanar orientation, such that the plurality of sample containers arenon-overlapping when viewed from at least one angle; a lid configured toengage and substantially seal the housing; and a sealing membercomprising a body and at least one protrusion extending from a surfaceof the body, the at least one protrusion configured to be inserted intoan substantially seal a sample access opening formed in a sidewall of atleast one of the sample containers, wherein the flexible member isextended away from the sample containers along a longitudinal directionof the tissue storage assembly wherein the housing contains the tissuestorage assembly therein, wherein the sealing member is a structurearranged on an inner wall of the housing and is projected in a firstdirection, from the inner wall to the assembly insertion opening, so asto engage and seal the sample access opening by abutting the sampleaccess opening, and wherein the first direction is parallel to a seconddirection through which the assembly insertion opening of the housingreceives the tissue storage assembly, wherein the sealing membercomprises an annular shaped member disposed at a bottom of the housing,and the at least one protrusion of the sealing member extending upwardfrom the annular shaped member, and wherein the tissue storage assemblyis inserted into the housing such that the sample access opening formedin the sidewall of the holding structure of the at least one samplecontainer is oriented downward to engage the at least one protrusion ofthe sealing member.